Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry

• Sponsor: Kaiser Franz Josef Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01515345
• Collaborator: (none)
• Enrollment: 1,008
• Location: 1
• Arms: 2
• Duration (Months): 18.1
• Patients Per Site Per Month: 55.8

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating "on-treatment" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).

Condition or Disease	Intervention/Treatment	Phase
Platelet Inhibition; Coronary Stent Implantation	Drug: prasugrel or ticagrelor; Drug: Clopidogrel	Phase 3

Detailed Description

Depending on the clinical presentation patients are treated according to standard operating procedures in our department. The earliest, 12 hours after an initial clopidogrel-loading dose (600mg)"on-treatment" platelet reactivity will be determined by Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer), a point of care assay. In case of high residual platelet reactivity (i.e. ≥ 50U), patients are switched according to a therapeutic algorithm to either prasugrel (Efient®), or in case of contraindication (i.e. stroke) to ticagrelor (Brilique®), or in case of contraindication (intracranial hemorrhage) reloaded with clopidogrel.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1008 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: standard therapy standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	Drug: Clopidogrel; clopidogrel 75mg od for 12 month; Other Names: Plavix
Experimental: individualized therapy dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer	Drug: prasugrel or ticagrelor; prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month; Other Names: Efient Brilique

Outcome Measures

Primary Outcome Measures

1. Definite Stent Thrombosis [30 days]

   The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"

2. Any Bleeding Event [30days]

   Bleeding classified by the TIMI hemorrhage classification scheme: Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL

Secondary Outcome Measures

1. Probable Stent Thrombosis [30days]

   Probable stent thrombosis is considered to have occurred in case of any unexplained death within the first 30 days. any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all consecutive PCI patients with stent implantation of our institution

Exclusion Criteria:

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Franz Josef Hospital	Vienna		Austria	1100

Sponsors and Collaborators

• Kaiser Franz Josef Hospital

Investigators

• Principal Investigator: Guenter Christ, MD, Kaiser Franz Josef Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• Bonello L, Camoin-Jau L, Arques S, Boyer C, Panagides D, Wittenberg O, Simeoni MC, Barragan P, Dignat-George F, Paganelli F. Adjusted clopidogrel loading doses according to vasodilator-stimulated phosphoprotein phosphorylation index decrease rate of major adverse cardiovascular events in patients with clopidogrel resistance: a multicenter randomized prospective study. J Am Coll Cardiol. 2008 Apr 8;51(14):1404-11. doi: 10.1016/j.jacc.2007.12.044.
• Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillabower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105. doi: 10.1001/jama.2011.290. Erratum in: JAMA. 2011 Jun 1;305(21);2174. Stillablower, Michael E [corrected to Stillabower, Michael E].
• Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schömig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030.

• Responsible Party: Prof. Dr. Guenter Christ, Univ. Prof. Dr., Kaiser Franz Josef Hospital
• ClinicalTrials.gov Identifier: NCT01515345
• Other Study ID Numbers: IDEAL-PCI protocol 1.0
• First Posted: Jan 24, 2012
• Last Update Posted: Apr 25, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Prof. Dr. Guenter Christ, Univ. Prof. Dr., Kaiser Franz Josef Hospital: clopidogrel-nonresponder; stent thrombosis
• Additional relevant MeSH terms: Clopidogrel; Ticagrelor; Prasugrel Hydrochloride

Study Results

Participant Flow

Recruitment Details	all consecutive PCI patients with stent implantation or drug eluting balloon dilation in our institution until June 2012

Arm/Group Title	Standard Therapy	Individualized Therapy
Arm/Group Description	standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Period Title: Overall Study
STARTED	665	343
COMPLETED	664	343
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Standard Therapy	Individualized Therapy	Total
Arm/Group Description	standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer	Total of all reporting groups
Overall Participants	665	343	1008
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	333 50.1%	169 49.3%	502 49.8%
>=65 years	332 49.9%	174 50.7%	506 50.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65 (12)	64 (12)	65 (12)
Sex: Female, Male (Count of Participants)
Female	183 27.5%	120 35%	303 30.1%
Male	482 72.5%	223 65%	705 69.9%
Region of Enrollment (participants) [Number]
Austria	665 100%	343 100%	1008 100%

Outcome Measures

1. Primary Outcome

Title	Definite Stent Thrombosis
Description	The angiographic or pathological confirmation of stent thrombosis is called "definite stent thrombosis"
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Therapy	Individualized Therapy
Arm/Group Description	standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Measure Participants	664	343
Number [participants]	1 0.2%	0 0%

2. Primary Outcome

Title	Any Bleeding Event
Description	Bleeding classified by the TIMI hemorrhage classification scheme: Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL
Time Frame	30days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Therapy	Individualized Therapy
Arm/Group Description	standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Measure Participants	664	343
Number [participants]	17 2.6%	9 2.6%

3. Secondary Outcome

Title	Probable Stent Thrombosis
Description	Probable stent thrombosis is considered to have occurred in case of any unexplained death within the first 30 days. any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure
Time Frame	30days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Therapy	Individualized Therapy
Arm/Group Description	standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)	dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
Measure Participants	664	343
Number [participants]	2 0.3%	0 0%

Adverse Events

Adverse Event Reporting Description	it was not intended to collect adverse events, other than SAEs
Arm/Group Title	Standard Therapy		Individualized Therapy
Arm/Group Description	standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)		dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
All Cause Mortality
	Standard Therapy		Individualized Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Therapy		Individualized Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/664 (3.9%)		18/343 (5.2%)
Cardiac disorders
Definite stentthrombosis	1/664 (0.2%)	1	0/343 (0%)	0
probable Stentthrombosis	2/664 (0.3%)	2	0/343 (0%)	0
Cardiovascular death	6/664 (0.9%)	6	9/343 (2.6%)	9
Bleeding (TIMI major)	6/664 (0.9%)	6	4/343 (1.2%)	4
Bleeding (TIMI minor)	11/664 (1.7%)	11	5/343 (1.5%)	5
Other (Not Including Serious) Adverse Events
	Standard Therapy		Individualized Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.